Phase 3 study of Ketotransdel for pain

Transdel announced positive results from its Phase 3 trial of Ketotransdel cream (ketoprofen 10% or TDLP-110) for the reduction of pain associated with acute soft tissue injuries. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of Ketotransdel in 326 patients with acute soft tissue injury pain. Patients treated with Ketotransdel demonstrated greater reductions from baseline in pain intensity during daily activity over the previous 24 hours at the Day 3 visit , the primary endpoint, than patients treated with placebo (p=0.038). Additionally, the proportion of patients who were satisfied with the treatment and achieved moderate or higher pain relief, as recorded on a seven-point Likert Scale, was greater with Ketotransdel (p=0.023) than placebo, time to onset of meaningful pain relief was about 40 minutes faster, and time to end of meaningful analgesic effect was approximately 45 minutes longer with Ketotransdel therapy.

Ketotransdel utilizes Transdel's proprietary transdermal delivery platform to deliver ketoprofen, a non-steroidal anti-inflammatory drug, through the skin directly into the underlying tissues where it exhibits its anti-inflammatory and analgesic effects.

For more information call (858) 457-5300 or visit www.transdelpharma.com.